Qnostics is a leading provider of molecular quality reagents and custom manufacture solutions. Qnostics specializes in the development, manufacture and distribution of Infectious Diseases Molecular Controls for use within the standard procedures of today’s molecular laboratory and Nucleic Acid Testing (NAT) assays.
Verification and Validation panels are designed to evaluate and establish the assay parameters of the molecular method and determine its fitness for purpose. These panels are typically used to evaluate molecular assay characteristics such as: Sensitivity, Specificity, Linearity, Precision, Accuracy, and Reportable Range. Additionally, Evaluation panels can be used for verification and validation of clinical assays, development of diagnostic tests and training of laboratory personnel.
Analytical Q Panels
Analytical ‘Q’ Panels are designed to cover the dynamic range of an assay allowing the laboratory to assess the linearity, LOD and LOQ of their assay. Each panel contains samples covering the dynamic range of most assays, in a linear progression, all of which should be treated as a patient sample within an assay run. The Analytical ‘Q’ panels serve to support validation of new assays and/or instrumentation.
Molecular Q Panels
Qnostics’ Molecular ‘Q’ Panels are intended to help laboratories evaluate their assays’ analytical measurement parameters and monitor their molecular diagnostic assay procedures. The panels can also be used to support laboratory training and in the assessment and development of molecular diagnostic assays from extraction phase through amplification to detection.
Qnostics’ ‘Q’ Controls are positive run controls intended to help laboratories monitor their molecular diagnostic assay on a run to run basis within customer derived limits. These third-party independent external controls will ensure that assay drift is detected, monitored and managed allowing the laboratory to continue to provide accurate and reliable results. They also help support a laboratory’s regulatory requirements under the standard ISO 15189:2012.